FEIBA NF anti-inhibitor coagulant complex

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ANTI-INHIBITOR COAGULANT COMPLEX (UNII: CS849DUN3M) (ANTI-INHIBITOR COAGULANT COMPLEX - UNII:CS849DUN3M)

Available from:

Baxter Healthcare Corporation

INN (International Name):

ANTI-INHIBITOR COAGULANT COMPLEX

Composition:

ANTI-INHIBITOR COAGULANT COMPLEX 25 [USP'U] in 1 mL

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

FEIBA NF- ANTI-INHIBITOR COAGULANT COMPLEX
BAXTER HEALTHCARE CORPORATION
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FEIBA NF (ANTI-INHIBITOR COAGULANT COMPLEX)
NANOFILTERED AND VAPOR HEATED
LYOPHILIZED POWDER FOR SOLUTION
INTRAVENOUS
WARNING
THROMBOTIC AND THROMBOEMBOLIC EVENTS HAVE BEEN REPORTED DURING
POSTMARKETING
SURVEILLANCE FOLLOWING INFUSION OF FEIBA VH OR FEIBA NF, PARTICULARLY
FOLLOWING THE
ADMINISTRATION OF HIGH DOSES AND/OR IN PATIENTS WITH THROMBOTIC RISK
FACTORS (SEE
WARNINGS, PRECAUTIONS AND ADVERSE REACTIONS).
DESCRIPTION
FEIBA NF (Anti-Inhibitor Coagulant Complex), nanofiltered and vapor
heated, is a freeze-dried sterile
human plasma fraction with Factor VIII inhibitor bypassing activity._
In vitro_, FEIBA NF shortens the
activated partial thromboplastin time (APTT) of plasma containing
Factor VIII inhibitor. Factor VIII
inhibitor bypassing activity is expressed in arbitrary units. One unit
of activity is defined as that amount
of FEIBA NF that shortens the APTT of a high titer Factor VIII
inhibitor reference plasma to 50% of
the blank value.
FEIBA NF contains Factors II, IX, and X, mainly non-activated, and
Factor VII mainly in the activated
form. The product contains approximately equal unitages of Factor VIII
inhibitor bypassing activity and
Prothrombin Complex Factors. In addition, 1–6 units of Factor VIII
coagulant antigen (FVIII C:Ag) per
mL are present. The preparation contains only traces of factors of the
kinin generating system. It
contains no heparin.
Reconstituted FEIBA NF contains 4 mg of trisodium citrate and 8 mg of
sodium chloride per mL.
FEIBA NF is manufactured from large plasma pools of human plasma.
Screening against potentially
infectious agents begins with the donor selection process and
continues throughout plasma collection
and plasma preparation. Each individual plasma donation used in the
manufacture of FEIBA NF is
collected only at FDA approved blood establishments and is tested by
FDA licensed serological tests
for Hepatitis B Surface Antigen (HBsAg), and for antibodies to Human
Immunodeficiency Vir